References

Charlton BG (1996) Megatrials are based on a methodological mistake. Br J Gen Pract 46: 429-31. Friedman LM, Furberg CD, DeMets DL (1985) Fundamentals of Clinical Trials. Mosby-Year Book: St. Louis, MO. Hammer CE (1990) Drug Development, CRC Press: Boca Raton, FL.

Hampton JR (1996) Alternatives to mega-trials in Cardiovascular Disease. Cardiovasc Drugs Ther 10: 759-65. Makuch RW, Johnson MF (1986) Some issues in the design and interpretation of 'negative' clinical studies. Arch Intern Med 146: 986-9.

Makuch, RW, Johnson Mary F (1989). Issues in planning and interpreting active control equivalence studies. J Clin Epidemiol 42(6): 503-11. Spilker B (1991) Guide to Clinical Trials, Raven: New York, NY.

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